20 minutes after eating an Impossible Burger for the first time, a man Tweeted ,“went into anaphylactic shock & taken to ER”

EXCERPT: “Modified soy leghemoglobin has never been part of the human diet before. Yet, Impossible Foods introduced this genetically-engineered protein into the marketplace with no real data and despite the FDA having serious concerns about its safety. It is outrageous,” said Dr. Michael Hansen of Consumers Union.—

Impossible Foods is “misleading consumers” about its GMO protein, FDA rejects the claim that it is safe for consumption

* Impossible Foods is “misleading consumers” about the key ingredient in the Impossible Burger.

* The Company told the U.S. Food & Drug Administration (FDA) that its soy leghemoglobin was “substantially similar” to proteins consumed daily by the global population, in the form of meat and other vegetables.

However, on the Impossible Foods website, it claims that the heme in the Impossible Burger is “identical” to the heme humans have been consuming for hundreds of thousands of years in meat and other foods.

* The FDA told Impossible Foods that its arguments “do not establish safety of SLH (soy leghemoglobin) for consumption.” The company decided to sell the Impossible Burger to the public anyway.

* Impossible Foods relied on the expert testimony of scientists who have worked for or have links to Monsanto, the Gates Foundation, Philip Morris and all of the major biotechnology companies.

* 20 minutes after eating an Impossible Burger for the first time, a man Tweeted, “went into anaphylactic shock & taken to ER”.—One of the biggest stories in the food world over the past few years has been the Impossible Burger, the plant-based burger that bleeds when you bite into it.

The goal of the Impossible Burger is to help make a dent in climate change by offering a plant-based burger that does not come from an animal. Animals require a tremendous amount of water and feed, and also produce greenhouse gases. Because the burger is made from plants, the other thing that the Impossible Burger would do is to help alleviate the killing of animals.

Impossible Foods, which makes the Impossible Burger and has raised $257 million in venture capital funding from Khosla Ventures, Bill Gates and others, has captivated the food media landscape and vegans everywhere because it offered a burger-eating experience yet with no animals involved.

But as The New York Times reported today and as found in documents under a Freedom of Information Act (FOIA) request, information has been uncovered that raises very serious questions about the safety of the Impossible Burger.

HOW THE IMPOSSIBLE BURGER IS MADE

The key to the Impossible Burger is making the burger look and taste like a regular hamburger. Impossible Foods accomplishes this, at scale, through genetic engineering.

Impossible Foods begins with the gene for a protein called leghemoglobin, a heme protein that is naturally found in the root nodules of soy plants. It then takes a strain of genetically-engineered yeast and adds the soy leghemoglobin gene, and proceeds to grow the yeast via the fermentation process. The company isolates the leghemoglobin, or heme, from the yeast and adds that genetically-engineered protein to the Impossible Burger.

HOW IMPOSSIBLE FOODS IS “MISLEADING CONSUMERS”

First, the company says on its webste that “heme” in naturally-occurring soy roots is also referred to as soy leghemoglobin.

Impossible Foods then goes on to say that the heme that the company is using is produced through genetic modification, thereby making it a first-of-its-kind protein.

But then it goes on to say that:

“The heme in the Impossible Burger is ‘identical’ to the heme humans have been consuming for hundreds of thousands of years in meat and other foods.”

“The way in which Impossible Foods is loosely and interchangeably using the word “heme” is misleading consumers. The average person with no scientific background would reasonably read the FAQ section of this website and think that the genetically-engineered heme in the Impossible Burger is ‘identical’ to the heme that humans have been consuming for hundreds of thousands of years in meat and other foods. This is categorically not true,” Michael Hansen, Ph.D. and Senior Scientist at Consumers Union, a division of Consumers Reports.

An email to Impossible Foods asking “How could the heme in the Impossible Burger be “identical” to the heme humans have been consuming for hundreds of thousands of years in meat and other foods if you genetically engineer it?” has yet to be returned.

While Impossible Foods makes a claim on its website that the heme in the Impossible Burger is “identical” to the heme humans have been consuming for hundreds of thousands of years in meat and other foods, the company makes a different claim to the FDA, as was uncovered in documents under the FOIA request.

On May 29, 2015, Gary Lingling, Senior Counsel at Morgan, Lewis & Bockius, sent a letter to Lauren Brookmire, Consumer Safety Officer at the U.S. Food & Drug Administration regarding “Response to FDA Questions – GRAS Notice 540 – Soybean Leghemoglobin – Impossible Foods, Inc.” This entire document is to address the safety concerns the FDA had about soy leghemoglobin – the most critical ingredient in the Impossible Burger.

On Page 1 of this document, the safety of soy leghemoglobin is being discussed. It says:

“Though the protein (soy leghemoglobin) is isolated from the root nodule, it is ‘substantially similar’ to proteins consumed daily by the global population, in the form of meat and other vegetables.”

On Page 6 of this document, research about the allergenicity of soy leghemoglobin is being discussed. It says:

“Impossible Foods recognizes that with any novel protein introduced to the diet, there is a risk of allergenicity.”

While Impossible Foods is making a general statement about novel proteins, it is doing so because its protein (the soy leghemoglobin) is novel. If it is novel, that would mean that it is new and has never been in the human diet before.

“To the FDA, the company is being very clear that this soy leghemoglobin is ‘substantially similar’ to proteins consumed daily by the global population, in the form of meat and other vegetables. On its website, the company says that the heme in the Impossible Burger is ‘identical’ to the heme that humans have been consuming for hundreds of thousands of years in meat and other foods. But this is an important difference that consumers are being misled about,” said Dr. Michael Hansen.

The entire issue with the FDA is around the safety of this soy leghemoglobin, and the exact nature of this protein is a very, very big deal. People should not dismiss the distinction between “substantially similar” and “identical”.

“Consumers must understand that these slight differences in proteins can have severe consequences to human health. If you make one amino acid change in human hemoglobin, you have sickle cell anemia,” offered Dr. Michael Hansen.

FDA SAYS IMPOSSIBLE FOODS’ ARGUMENTS “DO NOT ESTABLISH SAFETY”

On September 4, 2014, Impossible Foods submitted to the FDA its GRAS notification for its Soybean Leghemoglobin Protein Derived from Pichia pastoris. This notification can be found HERE.

Nearly a year later, on August 3, 2015, in a document prepared for a telephone conversation between the FDA and Impossible Foods, the FDA wrote:

“FDA believes that the arguments presented, individually and collectively, do not establish the safety of SLH (soy leghemoglobin) for consumption, nor do they point to a general recognition of safety, as explained below.”

Several months after this phone call, on November 10, 2015, Gary Lingling, Senior Counsel at Morgan, Lewis & Bockius, sent another letter to Lauren Brookmire, Consumer Safety Officer at the U.S. Food & Drug Administration regarding “Withdrawal of GRAS Notice 540”. The letter was to ask the FDA to withdraw company’s GRAS notification for soy leghemoglobin.

“When Impossible Foods submitted its notification for GRAS to the FDA in 2014, it said that it did not have any safety testing for that specific molecule (the modified soy leghemoglobin). The company’s argument was that it was similar to proteins consumed daily by the global population, in the form of meat and other vegetables. Claiming that it is safe because it is similar to other proteins eaten by consumers is simply not valid,” said Dr. Michael Hansen.

Since the withdrawal of the GRAS notification, Impossible Foods has been in discussions with the FDA about submitting additional data. The company’s goal is to receive a “no questions letter” from the FDA regarding the GRAS notification, which would indicate that the FDA agrees with Impossible Foods regarding the conclusion of the soy leghemoglobin produced by Pichia pastoris under its conditions of use and that it meets a general recognition of safety.

As of the publication of this story, the FDA has not granted to Impossible Foods this “no questions letter.”

Even though it is still seeking this “no questions letter” from the FDA, Impossible Foods “self-affirmed” its GRAS status in 2014 through a panel of hired experts. This “self-affirmed” GRAS status is fully allowed under the law, but the basis for this “self-affirmation” was predicated on “conformational similarity or functional similarity among proteins.” The FDA did not agree with this basis when it said (above) that “conformational similarity or functional similarity among proteins is not an indication the safety of proteins for consumption.”

On the company’s website, it says that these experts, who granted Impossible Foods its “self-affirmed” GRAS status, come from the University of Nebraska, University of Wisconsin and Virginia Commonwealth University.

Yet, nowhere on the website does it list who these experts are.

In its 2014 GRAS notification submitted by Impossible Foods to the FDA, it was disclosed who these three panel members are.

* Joseph F. Borzelleca, Ph.D., is a Professor Emeritus at the Virginia Commonwealth University. In 2009, Dr. Borzelleca served on Monsanto’s expert panel for a GRAS notification for its stearidonic (SDA) omega-3 soybean oil. In 2009, Dr. Borzelleca served on Monsanto’s expert panel for a GRAS notification for its low saturate high oleic low linolenic soybean oil.

* Steve L. Taylor, Ph.D., is Co-Founder and Co-Director of the Food Allergy Research and Resource Program, and is a Professor with the Department of Food Science and Technology at the University of Nebraska in Lincoln.

On the website of the Department of Food Science and Technology at the University of Nebraska in Lincoln, it is disclosed that its graduate students have received funding for research and training from major biotechnology companies and the Gates Foundation. (Bill Gates is an investor in Impossible Foods.)

* Michael W. Pariza, Ph.D., is a Professor Emeritus at the University of Wisconsin at Madison. Dr. Pariza was a co-author on a study which said aspartame in the human diet would not affect nervous system function, learning or behavior.

Confirmed by The Center for Media and Democracy, Professor Pariza served on the Board of Trustees of the International Life Sciences Institute (North America), whose current members include corporate ag-biotech conglomerates, including Monsanto, DuPont, Archer Daniels Midland and others.

In an extensive analysis, The Center for Public Integrity wrote that Dr. Borzelleca, Dr. Taylor, and Dr. Pariza are “go-to” experts for the food industry when it comes to GRAS notifications and all of them served on the Scientific Advisory Board of Philip Morris.

Impossible Foods also enlisted Dr. Richard E. Goodman, a Research Professor at the Food Allergy Research and Resource Program at the University of Nebraska in Lincoln, to assess the potential allergenicity and toxicity of soy leghemoglobin. Dr. Goodman’s research findings were included in the GRAS application.

According to GMO Answers, Dr. Goodman was an Allergy Program Manager for the safety assessment of genetically-modified crops at Monsanto from 1997-2004 and he currently directs the AllergenOnline.org database project at the University of Nebraska in Lincoln, which is funded by the top six international agricultural biotechnology companies.

On his bio on the University of Nebraska in Lincoln, it says that Dr. Goodman has conducted research projects for major international biotechnology companies.

“At a minimum, the names of people who are paid to provide expert testimony regarding the safety of a novel food product should be fully disclosed on a company’s website. Consumers deserve full transparency,” said Dana Perls, Senior Food and Technology Policy Campaigner at Friends of the Earth.

ADDITIONAL UNKNOWN PROTEINS DISCOVERED

Impossible Foods has been seeking a “no questions letter” from the FDA for its GRAS notification for its Soybean Leghemoglobin Protein Derived from Pichia pastoris. However, as discovered in documents under the Freedom of Information Act (FOIA) request, there are other unknown and untested proteins in the Impossible Burger.

When Impossible Foods separated the modified soy leghemoglobin from the yeast after the fermentation process, 73% of what was extracted was soy leghemoglobin. 46 other proteins were discovered in that remaining 27%.

According to Dr. Michael Hansen, “These 46 proteins have not been in the human diet before but are nevertheless being presented in the Impossible Burger, with no safety assessment having been completed for the protection of consumers.”

IMPOSSIBLE BURGERS WERE SERVED TO CONSUMERS DESPITE FDA SAFETY CONCERN

Knowing that the company had not fully addressed the FDA’s safety concerns, Impossible Foods went to market anyhow and began selling the Impossible Burger to a handful of restaurants in 2016, debuting at New York’s Momofuku Nichi. Currently, it is for sale at a few dozen restaurants around the country.

Legally, Impossible Foods was allowed to start selling the Impossible Burgers to the public because the company’s expert panel “self-affirmed” its GRAS status, even though the FDA did not agree with these experts. There is no indication that information about safety concerns addressed by the FDA have been disclosed to the public, and the decision to start selling the Impossible Burger, given the circumstances, raises a lot of questions.

* Was it shared with the restaurants who started selling the Impossible Burger that the FDA had very serious safety concerns about the company’s heme (soy leghemoglobin)?

* Were all of the investors and board members of Impossible Foods also aware of this or that the FDA refused to grant Impossible Foods a “no questions letter” for its GRAS notification?

* Did these investors and board members of Impossible Foods sign off on the company selling the Impossible Burgers to the public, knowing that the FDA had safety concerns?

* Did Impossible Foods violate any securities laws when raising money from investors, by not disclosing the exact conversations with the FDA?

Pat Brown, CEO and Founder of Impossible Foods, is acutely aware of investors’ lack of willingness to dig underneath the covers. In May, he told TechCrunch that “it is truly astonishing how little diligence they (VCs) [venture capitalists] do in terms of the actual science that underlies some tech companies.”

* Have any customers had allergic reactions or even died, as a result of eating the Impossible Burger?

On Twitter, Steven Molino said that 20 minutes after eating his first Impossible Burger at Bareburger, he “went into anaphylactic shock & taken to ER. Never happened to me before…” His Tweet about going into “anaphylactic shock” has since been deleted.

High profile, venture-backed companies attempting to disrupt the food sector have experienced notable missteps as of late, including Soylent having four product recalls in 18 months and Hampton Creek having its products removed from Target over food safety concerns.

Impossible Foods can now be added to a growing list of Silicon Valley engineered-food companies that make wild promises and fail to deliver.

“Modified soy leghemoglobin has never been part of the human diet before. Yet, Impossible Foods introduced this genetically-engineered protein into the marketplace with no real data and despite the FDA having serious concerns about its safety. It is outrageous,” said Dr. Michael Hansen of Consumers Union.